Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

Yale University68 enrolled

Overview

This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Binge-Eating Disorder Obesity

Interventions

NB medication (Naltrexone Bupropion combination)DRUG

NB medication

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participated in acute treatment for binge-eating disorder and obesity; * Had a positive response to acute treatment; * Available for the duration of the treatment and follow-up (20 months); * Read, comprehend, and write English at a sufficient level to complete study-related materials; and * Able to travel to study location (New Haven, CT) for monthly visits. Exclusion Criteria: * Currently taking anti-depressant medications; * Currently taking opioid pain medications or drugs; * Currently taking medications that influence eating/weight; * History of seizures; * Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality); * Past or current anorexia nervosa, bulimia nervosa; * Pregnant or breastfeeding; * Medical status judged by study physician as contraindication.

Locations (1)

Yale School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Binge Eating Frequency (Continuous)

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Time frame: Post-treatment (4 months)

Change in Body Mass Index

BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.

Time frame: baseline and Post-treatment (4 months)

Secondary Outcomes

Binge Eating Frequency (Continuous)

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Time frame: 6-Month Follow-up

Binge Eating Frequency (Continuous)

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Time frame: 12-Month Follow-up

Change in Body Mass Index (BMI)

BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.

Time frame: Baseline to 6-Month Follow-up

Change in Body Mass Index

BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.

Time frame: Baseline to 12-Month Follow-up

Data from ClinicalTrials.gov

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